Methods and devices for use in performing pulmonary procedures

ABSTRACT

Systems, methods and devices for performing pulmonary procedures, and in particular treating lung disease. A flow control element includes a valve that prevents airflow in the inhalation direction but permits airflow in the exhalation direction. The flow control element is guided to and positioned at the site by a bronchoscope that is introduced into the patient&#39;s trachea and used to view the lungs during delivery of the flow control element. The valve may include one, two or more valve elements, and it may be collapsible for easier delivery. A source of vacuum or suction may be used to increase the amount of fluid withdrawn from the lung tissue. A device for measuring hollow structures, such as bronchioles, and a device for removing a previously-placed flow control element are disclosed as well.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates generally to methods and devices for usein performing pulmonary procedures, and more particularly, proceduresfor treating various diseases of the lungs.

2. Description of Related Art

Pulmonary diseases such as emphysema and chronic obstructive pulmonarydisease (COPD) reduce the ability of one or both lungs to fully expelair during the exhalation phase of the breathing cycle. The diseasedlung tissue is less elastic than healthy lung tissue, which is onefactor that prevents full exhalation of air. During breathing, thediseased portion of the lung does not fully recoil due to the tissuebeing less elastic. Consequently, the diseased (e.g., emphysematic) lungtissue exerts a relatively low driving force, which results in thediseased lung expelling less air volume than a healthy lung. The reducedair volume exerts less force on the airway which allows the airway toclose before all air has been expelled, another factor that preventsfull exhalation.

The problem is further compounded by the diseased, less elastic tissuethat surrounds the very narrow airways that lead to the alveoli (the airsacs where oxygen-carbon dioxide exchange occurs). This tissue has lesstone than healthy tissue and is typically unable to maintain the narrowairways open until the end of the exhalation cycle. This traps air inthe lungs and exacerbates the already-inefficient breathing cycle. Thetrapped air causes the tissue to become hyper-expanded and no longerable to effect efficient oxygen-carbon dioxide exchange. Applyingsuction to these narrow airways (a procedure proposed in the literaturefor deflating the diseased portion of the lung) may collapse the airwaysdue to the surrounding diseased tissue, thereby preventing successfulfluid removal.

In addition, hyper-expanded lung tissue occupies more of the pleuralspace than healthy lung tissue. In most cases, a portion of the lung isdiseased while the remaining part is healthy and therefore still able toefficiently carry out oxygen exchange. By taking up more of the pleuralspace, the hyper-expanded lung tissue reduces the amount of spaceavailable to accommodate the healthy, functioning lung tissue. As aresult, the hyper-expanded lung tissue causes inefficient breathing dueto its own reduced functionality and because it adversely affects thefunctionality of adjacent healthy tissue.

Lung reduction surgery is a conventional method of treating lungdiseases such as emphysema. A diseased portion of the lung is surgicallyremoved which makes more of the pleural space available to accommodatethe functioning, healthy portions of the lung. The lung is typicallyaccessed through a median stemotomy or small lateral thoracotomy. Aportion of the lung, typically the upper lobe of each lung, is freedfrom the chest wall and then resected, e.g., by a stapler lined withbovine pericardium to reinforce the lung tissue adjacent the cut lineand also to prevent air or blood leakage. The chest is then closed andtubes are inserted to remove air and fluid from the pleural cavity. Theconventional surgical approach is relatively traumatic and invasive,and, like most surgical procedures, is not a viable option for allpatients.

More recently proposed treatments include the use of devices that employRF or laser energy to cut, shrink or fuse diseased lung tissue. Anotherlung volume reduction device utilizes a mechanical structure that isused to roll the lung tissue into a deflated, lower profile mass that ispermanently maintained in a compressed condition. As for the type ofprocedure used, open surgical, minimally invasive and endobronchialapproaches have all been proposed. Another proposed device (disclosed inpublication no. WO 98/48706) is positioned at a location in the lung toblock airflow and isolate a part of the lung. The publication statesthat the occlusion device is introduced through an endobronchialdelivery device, and is resiliently deformable in order to provide acomplete seal against airflow.

The search for new and better treatments underscores the drawbacksassociated with existing pulmonary procedures. Accordingly, there is aneed in the art for improved methods and devices for performingpulmonary procedures, and in particular, treating lung diseases such asemphysema.

SUMMARY OF THE INVENTION

In one embodiment the invention provides a method for treating apatient's lung. The method includes steps of selecting a hollowstructure in a patient's lung, the hollow structure defining a pathwayfor conducting fluid flow in at least first and second directions, andallowing fluid flow within the pathway in the first direction whilecontrolling fluid flow in the second direction.

In another embodiment the invention provides a method for treating apatient's lung. This method includes steps of providing a valve whichallows fluid flow in a first direction and limits fluid flow in a seconddirection, and positioning the valve at a desired location in a lung ofa patient with the first direction corresponding to an exhalationdirection and the second direction corresponding to an inhalationdirection.

In another embodiment the invention provides a method for treating apatient's lung that includes steps of providing a flow control elementthat limits fluid flow in at least one direction, positioning the flowcontrol element at a location in a lung of a patient with the onedirection substantially corresponding to an inhalation direction, andremoving the flow control element after a period of time.

In another embodiment the invention provides a method for treating apatient's lung, the method comprising steps of selecting a hollowstructure in a patient's lung, the hollow structure defining a pathwayfor conducting fluid flow in at least first and second directions,applying suction to draw fluid through the pathway in the firstdirection, and substantially preventing fluid flow through the pathwayin the second direction.

In another embodiment the invention provides a system for treating apatient's lung. The system includes a flow control element sized andconfigured to be positioned in a hollow structure located in a patient'slung, the flow control element including a valve member that permitsfluid flow in a first direction while substantially preventing fluidflow in a second direction. A delivery device is sized and configured tobe guided to and positioned in or adjacent the hollow structure, and theflow control element is removably mounted on the delivery device.

In another embodiment the invention provides a system for treating apatient's lung. The system includes a measuring device for determiningthe approximate size of a hollow structure in a patient's lung, and aflow control element sized and configured to be positioned in a hollowstructure located in a patient's lung, wherein the flow control elementallows fluid flow in a first direction but substantially prevents fluidflow in a second direction.

In another embodiment the invention provides a system for treating apatient's lung. This system includes a flow control element sized andconfigured to be positioned in a hollow structure located in a patient'slung, wherein the flow control element allows fluid flow in a firstdirection but substantially prevents fluid flow in a second direction,and a removal device for removing the flow control element from thehollow structure subsequent to positioning the flow control element inthe hollow structure.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an elevation view schematically showing a system constructedaccording to one embodiment of the invention, the system being used toperform a pulmonary procedure on a patient;

FIG. 2 is an enlarged elevation view of the lungs of the patient shownin FIG. 1 along with the system of the invention;

FIG. 3 is an enlarged elevation view, in section, of a flow controlelement forming part of the system shown in FIG. 2, wherein the flowcontrol element allows fluid flow in a first direction but blocks fluidflow in a second direction;

FIG. 4 is an enlarged elevation view, in section, of an alternative flowcontrol element that allows fluid flow in a first direction but blocksfluid flow in a second direction;

FIG. 5 is an enlarged elevation view, in section, of another alternativeflow control element;

FIG. 6 is an enlarged elevation view, in section, of still anotheralternative flow control element;

FIG. 7 is a perspective view of an introducer constructed according toanother embodiment of the invention;

FIG. 8 is an enlarged perspective view of a portion of the introducershown in FIG. 7;

FIG. 9 is a perspective view of a delivery device constructed accordingto another embodiment of the invention for delivering a flow controlelement to a selected location in a patient's lung;

FIG. 10 is a perspective view of a measuring device constructedaccording to another embodiment of the invention for determining thesize of a hollow structure prior to disposing a flow control element inthe structure; and

FIG. 11 is a perspective view of a removal device constructed accordingto another embodiment of the invention for removing a flow controlelement that has already been positioned in a hollow structure.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

The present invention provides methods and devices for performingpulmonary procedures, for example, treating various lung diseases suchas emphysema and COPD. One preferred embodiment of the inventionprovides a flow control element that allows fluid flow in a firstdirection and controls fluid flow in a second direction. As used herein,fluid means gas, liquid, or a combination of a gas(es) and liquid(s). Inaddition, controlled fluid flow, as used herein, means that the flow isaltered in some manner, i.e., the flow is not unimpeded in the seconddirection. The specific manner in which fluid flow is controlled in thesecond direction depends on the construction of the flow controlelement. The flow control element may, for example, completely block,substantially block, limit, meter or regulate fluid flow in the seconddirection by a valve or other suitable structure.

As an example, when positioned in a hollow structure in a patient'sbody, such as a bronchiole in one of the lungs, the flow control elementis oriented to allow flow in the exhalation direction but prevent fluidflow in the inhalation direction. The flow control element has a valvemember that opens during exhalation in order to deflate or decompressthe isolated lung portion distal to the flow control element. Thismaintains the diseased tissue in a decompressed state which preventsfurther hyper-expansion of the tissue. The invention also permits slowdecompression of the lung tissue over a short or extended period oftime.

The invention thus may be used to prevent fluid being drawn into one oremore portions of a patient's lung. According to another aspect of theinvention, a portion of the lung may be deflated by applying gentlesuction (via the flow control element) to the hyper-expanded tissuewithout collapsing the walls of the narrow airways surrounded bydiseased tissue. The suction draws air, liquid, mucous, etc., out of thelung portion to evacuate the diseased tissue. It will be recognized thatthese and other aspects of the invention may be practiced independentlyor in conjunction with each other.

FIG. 1 is a schematic view showing a system 10 constructed according toone embodiment of the invention for carrying out a pulmonary procedureon the lung L of a patient P. It should initially be noted that suitablesystems, methods or devices outside of those specifically describedherein may be used to practice the invention. As such, the system 10 isexemplary only and includes a bronchoscope 12 having a steeringmechanism schematically indicated at 14, a shaft 16, and a port 18 whichprovides access to one or more working channels of the bronchoscope.

FIG. 1 shows a delivery device 20 constructed according to theinvention. The delivery device 20 is shown positioned in thebronchoscope 12 in order to deliver a flow control element 22. Thebronchoscope 12 has been passed into the patient's trachea T and guidedinto the right bronchus 24. The delivery device 20 is then manipulatedwith respect to the bronchoscope 12 via steering mechanism 14 to controlplacement of the flow control element 22. With reference to FIGS. 1 and7-9, the delivery device 20 is movable within a bronchoscope workingchannel 26 (FIG. 8) and is guided into the desired location in thehollow structure, which in this case is a bronchiole 28. For purposes ofexplanation, the bronchiole 28 feeds an upper lobe U of the lung L whichrepresents a diseased lung portion. The delivery device 20 is placedthrough the side port 18 and into the working channel 26, the distal end30 of the delivery device 20 is moved out of the working channel, andthe flow control element 22 is secured in position in the bronchiole 28.

FIG. 2 is an enlarged view of the patient's lungs L shown in FIG. 1after the introducer 12 and delivery device 20 have been removed, theflow control element 22 being left in the bronchiole 28. The flowcontrol element 22, shown in more detail in FIG. 3, is in the form of avalve with a valve member 32 supported by a ring 34. It should be notedthat FIG. 2 also illustrates a second flow control element 22A placed ina bronchiole 28A that feeds a lower lobe LL of the lung. The flowcontrol element 22A includes a valve member 32A and a support ring 34Aand reduces or prevents fluid from being inhaled into the hyper-expandedtissue of the lower lobe LL. It will be understood that any number offlow control elements may be used in a given procedure.

Referring to FIG. 3, which shows the flow control element 22 in detail,the valve member 32 is a duckbill-type valve and has two flaps definingan opening 36. The valve member 32 is shown in a flow-preventingorientation in FIG. 3 with the opening 36 closed. The valve member 32 isconfigured to allow fluid flow in a first direction (along arrow A)while controlling fluid flow in a second direction (along arrow B). Inthis embodiment, fluid flow in the direction of arrow B is controlled bybeing completely blocked by valve member 32. The first and seconddirections in which fluid flow is allowed and controlled, respectively,are preferably opposite or substantially opposite each other, forexample, as shown in the Figures. It will be appreciated, though, thatthe invention may be practiced with the first and second directionsdifferent but not opposite each other.

As noted above, the valve member 32 of the flow control element 22controls fluid flow by completely blocking such flow in the seconddirection. As such, the valve member 32 effectively functions as aone-way valve. Alternative embodiments of the invention utilize flowcontrol elements that controls fluid flow in the second directionwithout completely blocking such flow.

FIG. 4 shows an exemplary flow control element 38 constructed accordingto an alternative embodiment of the invention that limits, but does notblock, fluid flow in at least one direction. The flow control element 38comprises a valve member 40 supported by a ring 42. The valve member 40is preferably a duckbill-type valve having a similar construction tothat of the valve member 32, except that the flaps 44 are formed,secured, oriented or otherwise configured to maintain a flow opening 46when in their flow-controlling (as opposed to flow-allowing)orientation. The opening 46 is sized and configured to achieve desiredflow characteristics through the flow control element 38.

When the flow control element 38 is in its flow-allowing orientation(not shown), the flaps 44 spread apart and allow essentially unimpededfluid flow out of the diseased lung portion. When the flow controlelement 38 is in its flow-controlling orientation, as shown in FIG. 4,the flaps move together to define opening 46 which allows apredetermined amount of fluid to be inhaled into the lung portion. Thisis in contrast to flow control element 22 which blocks fluid flow intothe lung when in a flow-controlling orientation. It will of course berecognized that FIG. 4 shows only one way to achieve limited fluid flowin a given direction. The specific manner in which flow control isobtained may vary according to the invention, e.g., by varying thenumber, size, shape or position of the flow openings on the flow controlelement.

According to another aspect of the invention, the flow control elementmay be constructed to provide a pumping action that aids in moving gasor liquid within a hollow structure, such as a bronchiole. For instance,when the lung distorts during inhalation and/or exhalation, a mechanicalpumping action is produced that may be used to move the gas or liquid tofurther deflate the isolated region of the lung. FIG. 5 shows anexemplary flow control element 50 constructed according to thisembodiment and including a pair of valve members 52, 54 supported inseries by a ring 56. The valve members 52, 54 each include a pair offlaps defining a valve opening (the valve members being shown in theirclosed, fluid flow blocking orientation in FIG. 5). A chamber 58 isdefined between the valve members 52, 54 and produces a pumping effecton the fluid flowing through the flow control element 50. The chamberwould collapse and expand with movement of the bronchiole (or otherhollow structure in which it is inserted) to pump fluid from thediseased lung tissue.

The valve member 54 is coupled to a bellows 60 to enhance the pumpingaction and/or to control the amount of force needed to open the valvemember. The wall 62 defining the chamber 58 is secured to the ring 56 sothat the chamber 58 occupies the entire interior of the ring 56. Theflow control element 50 may have a different configuration wherein thechamber 58 is defined by an air pocket located within the wall 62. Thismay prevent fluid collecting in the chamber 58. In addition, apower-driven pump may be used to draw fluid out of the lungs, e.g., aminiature battery-powered electric pump, or pumps that use physical orchemical characteristics, e.g., a change in air temperature, presence ofan additional gas or liquid, change in pH, etc., to generate pumpingforce that evacuates air and mucous.

FIG. 6 shows yet another alternative flow control element 70 including avalve member 72 comprising a pair of flaps defining an opening, and ring74 supporting the valve member 72. The valve member 72 is aduckbill-type valve that permits fluid flow in a first direction butprevents flow in a second direction. The ring 74 in this embodimentcomprises a stent 76 having struts 78 to enhance fixation of the flowcontrol element 70 in the hollow body structure (not shown). The valvemember 72 may be attached to the stent 76 by any suitable means, e.g.,suture, fasteners, adhesives, etc. The stent 76 is movable betweencollapsed and expanded (FIG. 6) orientations to enable easy delivery anddeployment. That is, the flow control element 70 including stent 76 maybe collapsed and held in a sheath for delivery through a relativelysmall space, for example, the working channel of a bronchoscope. (Atypical bronchoscope has a diameter of about 6 or 7 mm, while theworking channel has a diameter of about 2 or 3 mm.) Utilizing acollapsible flow control element may also be useful in introducing theflow control element through an small opening formed in the patient'sthorax.

FIGS. 7 and 8 show in detail the bronchoscope 12 and the flow controlelement delivery device 20 described above in connection with FIG. 1.The bronchoscope 12 has an eyepiece 80 which is used to visualize thetrachea and the various pathways of the lung during deployment of theflow control element 22. The bronchoscope 12 may be provided with acamera/recorder, an aspiration/irrigation system, or other auxiliaryfeatures. The steering mechanism 14 may comprise cables that move thedistal tip of the bronchoscope shaft 16 over a desired angular range,for example, 0° through 180°. FIG. 8 shows the distal portion 30 of thebronchoscope 12 including the working channel 26 (which communicateswith the side port 18), one or more fiber optic light guides 81, and alens 82 for transmitting images to the eyepiece 80.

FIG. 9 shows the delivery device 20 to include a handle 84, an actuator86, a support shaft 87 and a sheath 88. For purposes of illustration,the delivery device 20 will be described in connection with deliveringthe flow control element 70 of FIG. 6, although it will be understoodthat it may be used to deliver alternative flow control elements. Theflow control element 70, and in particular the stent 76, is collapsed toa low profile orientation and then mounted on the shaft 87. The sheath88 is moved distally from the position shown in FIG. 9 until it coversthe stent body 76 (and the valve member 72, if desired) to maintain theflow control element 70 collapsed. (This position of the sheath isomitted for clarity.) The shaft 87 and sheath 88 are then passed intothe side port 18 and working channel 26 of the bronchoscope 12 andguided to a desired location in the lung. The actuator 86 is used toremove the sheath 88 from the flow control element 70 which allows thestent 76 to expand. Stent 76 is preferably formed of a self-expandingmaterial, e.g., nitinol. In this case the flow control element 70immediately expands and engages the tissue upon retraction of sheath 88.Alternatively, the stents could rely on a mechanism such as a balloon orheat activation to expand in use.

The flow control element of the invention may be guided to andpositioned at a desired location in the pulmonary system, such as thebronchiole 28 shown in FIGS. 1 and 2, by various delivery devices orsystems. For example, guidewire-based systems, introducer sheaths,cannulae or catheters, etc., may be used to deliver the treatmentelement in a minimally invasive manner. The above-described method forusing a bronchoscope to introduce the flow control element may bemodified by placing an introducer sheath over the bronchoscope. Thesheath provides access should the bronchoscope need to be removed frompatient's body, for example, in order to place a different size flowcontrol element.

The invention is preferably carried out by first determining theapproximate size of the target lumen, i.e., the hollow structure inwhich the flow control element will be placed. FIG. 10 shows somewhatschematically an exemplary device for determining the size of a hollowstructure in a patient's body, for example, a bronchiole in a lung. Thedevice 90 includes a housing 92, shaft 94, positioning element, 96 andmeasuring elements 98. The measuring elements 98 have tips 100 that aremoved into contact with the wall of the hollow structure, such as theinner surface of a bronchiole (not shown). The device 90 is calibratedso that when tips 100 of measuring elements 98 engage the wall of thebronchiole the indicator 102 displays the approximate size of thebronchiole. An electrical coupling 104 powers the device 90.

The positioning element 96 is optional and may be used to fix theposition of the measuring elements 98 within the bronchiole so as toobtain more precise measurement. The illustrated element 96 is aninflatable balloon, although other elements could be used to center andhold the shaft 96 within the bronchiole. Any suitable means may be usedfor ensuring that the measuring elements 98 do in fact contact thebronchiole wall in order to provide a true reading. The measuringelements 98 may be moved distally (to the right in FIG. 10) until avisual indicator indicates that the tips 100 are in contact with tissue.Alternatively, a change in electrical resistance may be used to confirmcontact between the measuring elements 98 and tissue. It should be notedthat the device 90 is merely representative of the various means thatmay be used to determine the size of a hollow body structure.

In use, the shaft 94 of the measuring device 90 is passed through thebronchoscope working channel 26 and delivered to the site. The device 90is then operated as described above to determine the approximate size ofthe bronchiole. The degree of precision with which the size of thehollow structure is measured will depend on the procedure beingperformed and user preference. After determining the size of thebronchiole the device 90 is removed from working channel 26, anddelivery device 20 is inserted into the channel to deploy the flowcontrol element in the bronchiole.

It may in some instances be necessary or desirable to remove a flowcontrol element from a hollow structure in which it has been deployed.As an example, it may be the case that placement of a flow controlelement for a given period of time effects beneficial results on thediseased lung tissue. The time during which the diseased tissue isdeflated and decompressed may allow the tissue to regain some elasticityas a result of being temporarily inactive. After the tissue has regainedsome or all of its elasticity, it would be better to remove the flowcontrol element and allow the tissue to function efficiently. The flowcontrol element, however, is preferably not removed before the tissuehas a sufficient chance to recover.

Accordingly, the invention also provides methods and devices forremoving a flow control element from a hollow structure such as abronchiole in a patient's body. FIG. 11 shows a device 110 comprising ahandle 112, an actuator 114, a shaft 116 and one or more removalcomponents 118. The components 118 preferably have tips 120 configuredto grasp a flow control element in order to remove the element fromsurrounding tissue. The shaft 116 of the device 110 is passed into apatient's trachea (not shown) and is guided to the previously-deployedflow control element; for example, the shaft 116 may be introducedthrough the working channel of a bronchoscope in the same manner as thedelivery device 20. The removal components 118 are preferably collapsedwithin shaft 116 while the shaft is guided to the site. The components118 are then extended into contact with the wall of the bronchiole. Thetips 120 are used to grasp and remove the flow control element from thebronchiole.

The flow control element of the invention is secured in position in thehollow structure, such as bronchiole 28, so as to remain in place duringbreathing. The exterior of the flow control element may be configuredalong all or part of its exterior to aid in fixing the element in place,for instance, as schematically indicated by reference numeral 48 inFIGS. 3 and 4. The fixation structure 48 may comprise adhesives, tissuegrowth-inducing substances, fasteners, staples, clips, suture, stents,balloons, Dacron® sleeves, sintered, etched, roughened, barbed oralternatively treated surfaces, etc.

Placement of a flow control element constructed according to theinvention in a patient's pulmonary system achieves several benefits.With reference to the illustrated flow control element 22, when deployedin the bronchiole 28 as shown in FIGS. 1 and 2, the element allowsexhalation but prevents inhalation. The flow control element 22 thuslimits or prevents the inhalation of additional fluid into the diseasedlung portion. This is beneficial because it prevents further enlargementof the hyper-expanded tissue, which in turn maintains more room in thepleural space for healthy lung tissue. The flow control element 22 alsoallows any air being naturally exhaled by the patient (as well as anyliquid, if present) to exit the lung, thereby deflating or decompressingthe tissue. The fluid is preferably permitted to flow unimpeded from thelung, but it may instead be metered or regulated in order to controldeflation.

The flow control elements of the invention permit the diseased tissue togradually deflate, either under the patient's own power or by applyingrelatively gentle suction for a given period of time. The suction may beapplied intermittently or continuously by any suitable means. Forexample, a suction catheter could be passed through the flow controlelement in the bronchiole and into the distal tissue. The flow controlelement, for example, a valve member, would preferably seal around thecatheter in order to prevent fluid moving distally past the valve.

The invention thus provides significant benefits as it permits fluid tobe evacuated from the alveoli without collapsing the floppy walls of thenarrow airways leading to them, problem with common lung diseases suchas emphysema and COPD, as discussed above. Accordingly, the inventionfacilitates removal of more fluid from the diseased lung tissue thanprior art approaches, the effect of which is more plural space availableto the healthy lung tissue.

In addition, as noted above, using the invention to deflate the diseasedlung tissue for a selected period of time, e.g., one month, may havebeneficial results on the tissue by temporarily removing it from therespiratory circuit. The flow control element is preferably removedbefore the tissue begins to necrose, but is left in place a sufficientlylong enough time that the tissue will not revert to its floppy, tonelessstate when the element is removed. Stated otherwise, it may be possibleto use the invention as a means for repairing (rather than removing orobliterating) diseased lung tissue, either by controlling the fluid flowin the lung tissue or by controlling the fluid flow in combination withdelivering one or more substances.

For example, some possible substances with which the invention may beused include gene therapy or angiogenesis factors for lung repair orre-establishment of tissue elasticity; growth factors; anti-growth oranti-angiogenesis factors (or substances to cause necrosis or apoptosis)to prevent re-establishment of air and blood flow; antibiotics toprevent infection; anti-inflammatory agents including steroids andcortisones; sclerosing drugs or materials to promote rapid healing, forexample, to allow earlier removal of the flow control element; agentsfor absorbing remaining fluids; and sealing substances for enhancingisolation of the diseased tissue.

The portion of the lung being treated may be deflated over time throughrepeated natural inhalation and exhalation with the flow control elementin place. Alternatively or additionally, a vacuum source may be coupledto the flow control element to draw fluid out of the diseased tissue inthe manner discussed above. This deflation of the diseased portion maybe performed alone or in conjunction with delivering biologicalsubstances. The pressures used to suction the lung portion arepreferably low to avoid collapsing the walls of the narrow airways.

In the embodiments in which the flow control element comprises a valve,it may be formed of various materials and may be constructed in variousmanners. As an example, the valve may comprise an annulus or supportring formed of any suitable metal or synthetic material, with the valvemember being formed of silicone, natural rubber, latex, polyurethane,polytetrafluoroethylene, a thermoplastic elastomer, tissue, etc. Thevalve member may be integral with the support ring or it may be aseparate member attached thereto by suitable means, e.g., suture,adhesives, mechanical fasteners, etc. If the flow control elementcomprises a stent with a valve, prior art attachment methods may beused. For example, see U.S. Pat. No. 5,954,766, the content of which isincorporated herein by reference.

The specific characteristics of the flow control element may be varieddepending on the particular application. It may be desirable to providemultiple flow control elements with valve members that require differentexhale pressures to open, for example, in order to allow treatment ofpatients who generate different exhalation pressures. The different flowcontrol elements could be provided in a kit and be distinguished fromeach other based on required opening force, size, material, etc. The kitcould include a color or other coding system to indicate these factors.

The flow control elements of the invention are preferably constructed soas to require a relatively low opening force in order to allow fluidflow in the first direction. Emphysema patients typically exhale a smallquantity of low-pressure fluid. The invention preferably allows any suchfluid to escape via the flow control element in the hollow structure. Assuch, the flow control element is designed to open and allow flow in thefirst direction in response to any positive pressure generated by thepatient. Put another way, as long as some pressure differential existsbetween the distal lung tissue and the proximal portion of thebronchiole, the flow control element will open to allow fluid to escapethe tissue. It will nonetheless be recognized that the particular forcerequired to open the flow control element may be varied depending onexhalation pressures associated with the intended patient population.

It will be appreciated that features of the various preferredembodiments of the invention may be used independently or in conjunctionwith one another, while the illustrated methods and devices may bemodified or combined in whole or in part. The inventive devices mayinclude removable or detachable components, and may comprise disposableor reusable components, or a combination of disposable and reusablecomponents. Likewise, it will be understood that the invention may bepracticed with one or more of the steps specifically illustrated anddescribed herein modified or omitted.

It should also be recognized that the invention is not limited totreating lung diseases as is shown in the Figures, although that is apreferred application. The invention may be used in any pulmonary ornon-pulmonary procedure in which it is desirable to allow fluid flow ina first direction and control fluid flow in a second, differentdirection within a hollow structure. Finally, it will be understood thatalthough a minimally invasive, endobronchial approach is shown in theFigures, other approaches may used, for example, an open surgicalprocedure using a median stemotomy, a minimally invasive procedure usinga mini thoracotomy, or a still less invasive procedure using one or moreports or openings in the thorax, etc.

The preferred embodiments of the invention are described above in detailfor the purpose of setting forth a complete disclosure and for sake ofexplanation and clarity. It will be readily understood that the scope ofthe invention defined by the appended claims will encompass numerouschanges and modifications.

What is claimed is:
 1. A method for treating a patient's lung, themethod comprising steps of: (a) providing a flow control element whichallows fluid flow in a first direction and limits fluid flow in a seconddirection, wherein the providing step is carried out by providing avalve configured to pump fluid in the first direction, the valve havinga proximal valve portion, a distal valve portion, and a pumping chamberpositioned between the proximal and distal valve portions; (b)positioning the flow control element at a desired location in a lung ofa patient with the first direction corresponding to an exhalationdirection and the second direction corresponding to an inhalationdirection.
 2. The method of claim 1, wherein the positioning step iscarried out by delivering the valve to the desired location in the lungsvia the patient's trachea.
 3. The method of claim 2, wherein thepositioning step is carried out by delivering the valve through anintroducer positioned in the patient's trachea.
 4. The method of claim3, wherein the introducer comprises a bronchoscope having at least oneworking channel and a lens for visualizing a target site, and whereinthe positioning step is carried out by introducing a delivery devicesupporting the valve into the working channel of the bronchoscope. 5.The method of claim 1, further comprising the step of removing the valvesubsequent to carrying out the positioning step.
 6. The method of claim1, further comprising, prior to carrying out the positioning step,determining the approximate size of the desired location.
 7. The methodof claim 6, wherein the determining step is carried out using ameasuring device, and further comprising selecting an appropriatelysized flow control element based at least in part on the determined sizeof the location.
 8. The method of claim 7, wherein the measuring devicecomprises means for determining an internal dimension of a bronchiole.9. The method of claim 1, wherein the valve is selected from the groupconsisting of duckbill, flapper, tricuspid, ball and needle valves. 10.The method of claim 1, further comprising the step of applying suctionto at least part of the lung downstream of the valve.
 11. The method ofclaim 10, wherein the suction is applied intermittently.
 12. The methodof claim 11, wherein the valve is delivered through a working channel ofa bronchoscope, and the suction is applied through another channel ofthe bronchoscope.
 13. A method for treating a patient's lung, the methodcomprising steps of: (a) providing a flow control element which limitsfluid flow in at least one direction; (b) positioning the flow controlelement at a location in a lung of a patient with the one directionsubstantially corresponding to an inhalation direction; and (c) removingthe flow control element.
 14. The method of claim 13, wherein theproviding step is carried out by providing a flow control element thatblocks fluid flow in the one direction while allowing fluid flow inanother direction, and wherein the other direction corresponds to anexhalation direction.
 15. The method of claim 13, wherein the removingstep is carried out by removing the flow control element after apredetermined period of time.
 16. The method of claim 15, wherein thepositioning step is carried out by introducing the flow control elementthrough an introducer, the introducer having a first lumen through whichthe element is delivered to the location in the lung.
 17. The method ofclaim 16, wherein the introducer comprises a bronchoscope and the firstlumen corresponds to a working channel of the bronchoscope, and thepositioning step is carried out by delivering the flow control elementthrough the working channel.
 18. The method of claim 13, wherein theproviding step is carried out by providing a one-way valve that allowsunimpeded fluid flow in the one direction and completely blocks fluidflow in the other direction.
 19. The method of claim 13, furthercomprising the step of applying suction to a portion of the lung locateddownstream of the valve.
 20. The method of claim 13, wherein theproviding step is carried out by providing a valve configured to pumpfluid in the one direction.
 21. The method of claim 13, furthercomprising the step of determining a size of the location in the lungprior to performing the positioning step.
 22. A system for treating apatient's lung, the system comprising: a measuring device fordetermining the approximate size of a hollow structure in a patient'slung, wherein the measuring device has a flexible shaft and at least oneflexible measuring element that is moved into contact with the hollowstructure; and a flow control element sized and configured to bepositioned in a hollow structure located in a patient's lung, whereinthe flow control element allows fluid flow in a first direction andcontrols fluid flow in a second direction.
 23. The system of claim 22,further comprising a plurality of different size flow control elementsadapted to be placed in different size hollow structures.
 24. A systemfor treating a patient's lung, the system comprising: a flow controlelement sized and configured to be positioned in a hollow structurelocated in a patient's lung, wherein the flow control element allowsfluid flow in a first direction and controls fluid flow in a seconddirection; and a removal device for removing the flow control elementfrom the hollow structure subsequent to positioning the flow controlelement in the hollow structure.
 25. The system of claim 24, wherein theflow control element is configured to at least substantially preventsfluid flow in the second direction, and the removal device includes atleast one grasping element configured to grasp the exterior of the flowcontrol element.
 26. A method for treating a patient's lung, the methodcomprising steps of: providing a flow control element which restrictsfluid flow in at least a first direction, the flow control element beingreleasably coupled to a delivery device, wherein the delivery device hasa sheath; placing an introducer in a bronchial passageway of a patient'slung; inserting a bronchial access device through the introducer, thebronchial access device having a first channel and a second channel;positioning the delivery device in the second channel; and deploying theflow control element at the treatment site, the deploying stepcomprising moving the sheath relative to the flow control element. 27.The method of claim 26, further comprising visualizing a treatment sitein the patient's lung through the first channel.
 28. The method of claim26, wherein the bronchial access device comprises a bronchoscope. 29.The method of claim 26, wherein the flow control element restricts flowin only the first direction.
 30. The method of claim 29, wherein theflow control element comprises a valve.
 31. The method of claim 30,wherein the valve is selected from the group consisting of duckbill,flapper, tricuspid, ball and needle valves.
 32. The method of claim 26,wherein at least a portion of the flow control element has a firstdiameter before the deploying step and a second diameter when deployedat the treatment site, the first diameter being less than the seconddiameter.
 33. The method of claim 32, wherein the flow control elementcomprises a stent, and wherein during the deploying step the stentexpands from the first diameter to the second diameter.
 34. The methodof claim 26, wherein the flow control element is advanced through thesecond channel during the positioning step.
 35. The method of claim 26,wherein the delivery device is positioned in the second channel afterthe inserting step.
 36. The method of claim 26, further comprisingvisualizing the flow control element through the first channel duringthe step of deploying.
 37. The method of claim 26, wherein the bronchialaccess device includes a camera.
 38. The method of claim 26, wherein thevisualizing step comprises transmitting light through a lens.
 39. Themethod of claim 26, further comprising placing an introducer in thebronchial passageway, the inserting step comprising inserting thebronchial access device through the introducer.
 40. The method of claim26, wherein the inserting step comprises positioning a distal end of thebronchial access device in a first bronchial passageway and thedeploying step comprises placing the flow control element at a secondbronchial passageway branching from the first bronchial passageway. 41.The method of claim 26, further comprising, prior to carrying out thedeploying step, determining the approximate size of the treatment site,and selecting an appropriately sized flow control element based at leastin part on the determined size of the treatment site.
 42. The method ofclaim 41, wherein the determining step is carried out using a measuringdevice.
 43. The method of claim 42, wherein the measuring device isintroduced through the second channel.
 44. The method of claim 26,further comprising the step of applying suction to at least part of thelung located distally of the flow control element.
 45. A method fortreating a patient's lung, the method comprising steps of: providing aflow control element which restricts fluid flow in at least a firstdirection, the flow control element being releasably coupled to adelivery device; placing an introducer in a bronchial passageway of apatient's lung; inserting a bronchial access device through theintroducer, the bronchial access device having a first channel and asecond channel; positioning the delivery device in the second channel;and deploying the flow control element at the treatment site.
 46. Themethod of claim 45, further comprising visualizing a treatment site inthe patient's lung through the first channel.
 47. The method of claim45, wherein the bronchial access device comprises a bronchoscope. 48.The method of claim 45, wherein the flow control element restricts flowin only the first direction.
 49. The method of claim 48, wherein theflow control element comprises a valve.
 50. The method of claim 49,wherein the valve is selected from the group consisting of duckbill,flapper, tricuspid, ball and needle valves.
 51. The method of claim 45,wherein at least a portion of the flow control element has a firstdiameter before the deploying step and a second diameter when deployedat the treatment site, the first diameter being less than the seconddiameter.
 52. The method of claim 51, wherein the flow control elementcomprises a stent, and wherein during the deploying step the stentexpands from the first diameter to the second diameter.
 53. The methodof claim 45, wherein the flow control element is advanced through thesecond channel during the positioning step.
 54. The method of claim 45,wherein the delivery device is positioned in the second channel afterthe inserting step.
 55. The method of claim 45, further comprisingvisualizing the flow control element through the first channel duringthe step of deploying.
 56. The method of claim 45, wherein the bronchialaccess device includes a camera.
 57. The method of claim 45, wherein thevisualizing step comprises transmitting light through a lens.
 58. Themethod of claim 45, wherein the inserting step comprises positioning adistal end of the bronchial access device in a first bronchialpassageway and the deploying step comprises placing the flow controlelement at a second bronchial passageway branching from the firstbronchial passageway.
 59. The method of claim 45, further comprising,prior to carrying out the deploying step, determining the approximatesize of the treatment site, and selecting an appropriately sized flowcontrol element based at least in part on the determined size of thetreatment site.
 60. The method of claim 59, wherein the determining stepis carried out using a measuring device.
 61. The method of claim 60,wherein the measuring device is introduced through the second channel.62. The method of claim 45, further comprising the step of applyingsuction to at least part of the lung located distally of the flowcontrol element.
 63. A method for treating a patient's lung, the methodcomprising steps of: providing a flow control element which restrictsfluid flow in at least a first direction, the flow control element beingreleasably coupled to a delivery device; inserting a bronchial accessdevice in a bronchial passageway of a patient's lung, the bronchialaccess device having a first channel and a second channel; positioningthe delivery device in the second channel; deploying the flow controlelement at the treatment site; prior to carrying out the deploying step,determining the approximate size of the treatment site using a measuringdevice, wherein the measuring device is introduced through the secondchannel; and selecting an appropriately sized flow control element basedat least in part on the determined size of the treatment site.
 64. Themethod of claim 63, further comprising visualizing a treatment site inthe patient's lung through the first channel.
 65. The method of claim63, wherein the bronchial access device comprises a bronchoscope. 66.The method of claim 63, wherein the flow control element restricts flowin only the first direction.
 67. The method of claim 66, wherein theflow control element comprises a valve.
 68. The method of claim 67,wherein the valve is selected from the group consisting of duckbill,flapper, tricuspid, ball and needle valves.
 69. The method of claim 64,wherein at least a portion of the flow control element has a firstdiameter before the deploying step and a second diameter when deployedat the treatment site, the first diameter being less than the seconddiameter.
 70. The method of claim 68, wherein the flow control elementcomprises a stent, and wherein during the deploying step the stentexpands from the first diameter to the second diameter.
 71. The methodof claim 63, wherein the flow control element is advanced through thesecond channel during the positioning step.
 72. The method of claim 63,wherein the delivery device is positioned in the second channel afterthe inserting step.
 73. The method of claim 63, further comprisingvisualizing the flow control element through the first channel duringthe step of deploying.
 74. The method of claim 63, wherein the bronchialaccess device includes a camera.
 75. The method of claim 63, wherein thevisualizing step comprises transmitting light through a lens.
 76. Themethod of claim 63, wherein the inserting step comprises positioning adistal end of the bronchial access device in a first bronchialpassageway and the deploying step comprises placing the flow controlelement at a second bronchial passageway branching from the firstbronchial passageway.
 77. The method of claim 63, further comprising thestep of applying suction to at least part of the lung located distallyof the flow control element.